I. Field of the Invention
This invention relates to systems for storing pharmaceutical compounds. Specifically, the invention relates to combinations and methods for preventing the formation of aldehyde adducts of pharmaceutical compounds.
II. Description of Background and Related Art
It is conventional to store pharmaceuticals in glass vials stoppered with an elastomeric plug. The plug seals the vial while providing access for hypodermic needles. Considerable effort has been expended in the past in modifying such elastomeric stoppers.
U.S. Pat. No. 2,652,182 discloses coating rubber stoppers with silicone oil, vegetable oil, or certain esters to prevent the stoppers from adhering to each other when used in machines for automatically and mechanically stoppering vials.
U.S. Pat. No. 2,649,090 discloses a rubber stopper coated with a moisture-resistant, oily silicone lubricant to prevent the stopper form absorbing moisture by rendering it moisture-resistant.
U.S. Pat. No. 2,698,272 discloses coating an elastomeric stopper with a film of nylon or other thermoplastic synthetic resin to provide a method of forming a needle-penetrable sealing cap or stopper for a bottle.
U.S. Pat. No. 3,198,368 discloses a means for sealing a container comprising an inner layer of a tetrafluoroethylene polymer, and an outer layer of natural rubber superimposed over the inner layer. This combination of inner and outer layers permits the stopper to be punctured several times while maintaining sterile conditions inside the container.
U.S. Pat. No. 3,313,439 discloses a protective cap fitted on the internal surface of a rubber stopper to prevent the stopper from coming into contact with the contents of the container, thus serving to maintain the sterility of the solution inside the container. The cap is made of a thermoplastic material such as polypropylene or polyethylene.
U.S. Pat. No. 3,552,591 discloses a Teflon layer on the inner face of a rubber stopper. The Teflon layer is said to be less expensive than other materials, and permits a needle to be stuck through the entire stopper to withdraw the contents of the container.
U.S. Pat. No. 3,424,329 discloses a disc made of a fluorcarbon plastic that is placed on the inner face of an elastomeric stopper to reduce the potential for the contamination of the container contents.
U.S. Pat. No. 4,397,903 disclose a Teflon lining for the inner surface of an elastomeric stopper. This lining serves to aid in keeping the solution within the container sterile.
None of these improvements have been concerned with the leaching of gases from the elastomer, nor have others in the art known to the inventors identified any problem attendant the leaching of gases from elastomeric stoppers in the field of pharmaceutical containers.